CellEra Recalls
6 recalls on record · July 31, 2019 to March 23, 2022 · Medical Devices
Recalls by year
19
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 23, 2022Medical DevicesFDA
CellEra LLC recalls 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Hazard: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
March 23, 2022Medical DevicesFDA
CellEra LLC recalls 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Hazard: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
March 23, 2022Medical DevicesFDA
CellEra LLC recalls 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Hazard: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
March 23, 2022Medical DevicesFDA
CellEra LLC recalls 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Hazard: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
March 23, 2022Medical DevicesFDA
CellEra LLC recalls 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Hazard: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
July 31, 2019Medical DevicesFDA
CellEra LLC recalls VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Hazard: Adhesive border was not sticky enough.